MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381134
Medical Device Problem Codes	Leak/Splash (1354); Device Appears to Trigger Rejection (1524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
It was reported that bd angiocath catheter backs out of vein.The following information was provided by the initial reporter: since we have switch ref number in this product, we have had to change +++ artlines (ivs in the artery) in the same patient.Typically, one artline would last a patient a stay in icu.In the last month, we have been changing most of them daily.Very flimsy, as they fall out with barely any movement.We have not had this issue in the past.Great patient risk as multiple punctures are required, which are potential infection issues, bruising.Patient injury: no got a response from the customer on (b)(6) 2024 please clarify, is the catheter falling out while taped in place? this is correct.Taped and secured.Is this what is being referred to indicating that the a-line being replaced? correct.
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381134 and lot number 3201474.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, nine (9) unused samples were returned for evaluation by our quality team.Seven (7) samples belonged to lot 3201474 and two (2) samples belonged to lot 3058122.The blister packages were all intact/closed.Through inspection of the samples, no damages were observed with the catheter or any other component that could have resulted in the reported issue.Based on the provided feedback and images, it is understood that the customer is comparing the angiocath 20g x 1.16in product with the insyte 20g x 1.16in product; however, no damages were observed to determine a cause for this report.A probable cause may be related to the customer's perception when using a product with different characteristics; however, no quality defects have been identified.At this time, further action has not been determined necessary.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
No additional information.

• Brand Name: BD ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20126145
• Report Number: 9610048-2024-00142
• Device Sequence Number: 3227058
• Product Code: FOZ
• UDI-Device Identifier: 00382903811342
• UDI-Public: (01)00382903811342(11)230823(17)280731(10)3201474
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/14/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 381134
• Device Lot Number: 3201474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown